• Serve as the clinical program leader for one or more global, cross‑functional core teams—translating product strategy into executable clinical program plans and ensuring alignment with broader technical, regulatory, and business objectives. • Define and drive the clinical program roadmap, including strategy, requirements, milestones, and interdependencies across multiple complex studies. • Lead global study teams through all phases of execution—from early design and feasibility through study close‑out—ensuring scientific rigor, operational excellence, and compliance with worldwide Good Clinical Practice (GCP), ISO 14155, and other regional regulatory requirements. • Interface at a senior level with Executive Management, R&D, Regulatory Affairs, Quality, Operations, Marketing, and external partners/CROs to ensure technical and operational integration across program components. • Operationalize global clinical strategies, including study design approaches, regulatory evidence pathways, and site/country selection strategies informed by regional regulatory landscapes. • Oversee and manage complex program budgets, financial forecasting, and global resource allocation, ensuring optimal use of internal/external resources. • Establish and monitor KPIs for clinical execution, proactively identifying risks to study startup, enrollment, data quality, regulatory compliance, and program timelines—and driving mitigation strategies across global teams. • Lead vendor strategy and governance, including CRO and specialized vendor selection, contract oversight, performance management, and escalation resolution for multi‑region programs. • Implement innovative operational models and tools to optimize efficiency, quality, and scalability of global clinical execution (e.g., digital trial capabilities, centralized monitoring approaches, risk‑based quality management). • Represent the clinical program externally, providing senior‑level engagement with investigators, global KOLs, regulatory bodies (as appropriate), and other external stakeholders to ensure alignment on scientific and regulatory expectations. • Ensure integration of clinical insights into product development, partnering closely with R&D and technical program management teams to translate clinical outcomes into product improvements and future evidence needs.